FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
K Number: K100451
·
Decision Dec 21, 2010
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
37
Applicant Total
13
Review Days
307
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Basic Information
- Device Name
- GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
- K Number
- K100451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gambro Renal Products, Inc.
- Date Received
- February 17, 2010
- Decision Date
- December 21, 2010
- Product Code
- MPB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K131516 | PRISMAFLEX SYSTEM 7.10 | Jan 3, 2014 | Substantially Equivalent |
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | May 2, 2013 | Substantially Equivalent |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | Dec 14, 2012 | Substantially Equivalent |
| K110823 | PRISMAFLEX | Jun 17, 2011 | Substantially Equivalent |
| K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM | May 20, 2011 | Substantially Equivalent |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | Nov 3, 2010 | Substantially Equivalent |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | Jul 29, 2010 | Substantially Equivalent |
| K080519 | PRISMAFLEX M150 SET | Jun 13, 2008 | Substantially Equivalent |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | Sep 7, 2007 | Substantially Equivalent |